What is the study therapy?

  • The study therapy, called CLR 125, is a new drug in development. It is a targeted radiotherapeutic agent designed to specifically kill cancer cells.
  • CLR 125 works by delivering radiation (iodine-125, an Auger electron emitter) directly to cancer cells. CLR 125 is taken up by the cancer cells and delivers the radiation inside those cells. The radiation causes breaks in the DNA in cancer cells causing those cells to die. Because the emissions do not travel very far, normal tissues should not be impacted.
  • CLR 125 is administered intravenously 4 times in each 8-week cycle, for 4 to 8 months; each infusion takes up to 45 minutes.
  • Triple negative breast cancer can benefit from radiation therapy (1). Over 200 adult and pediatric cancer patients have been dosed in previous clinical studies with an agent similar to the study therapy, CLR 131 (the same molecule as CLR 125, with a different version of iodine). These include previous efficacy and safety studies where CLR 131 has been shown to be safe and help to treat hematologic diseases (like some lymphomas and brain tumors).
  • While this is the first study to evaluate CLR 125 in humans, because CLR 125 and CLR 131 are similar, researchers anticipate that the side effects of CLR 125 could be similar to those seen with CLR 131.
  • The study therapy uses a radioactive version of iodine, which the thyroid absorbs easily. Because of this, participants will take an approved drug during each cycle of the study therapy to protect the thyroids from radiation absorption. 1: de Faria Bessa J, Marta GN. Triple-negative breast cancer and radiation therapy. Rep Pract Oncol Radiother. 2022 Jul 29;27(3):545-551. doi: 10.5603/RPOR.a2022.0025. PMID: 36186688; PMCID: PMC9518779.

What is an investigational therapy?

  • CLR 125 is an investigational study therapy.
  • An investigational study therapy is one that has not been approved by the US Food and Drug Administration (FDA) or any other regulatory agency.

What is a Radiopharmaceutical?

  • A drug attached to a radioactive molecule is called a radiopharmaceutical, also known as a radioactive drug. The drug attached to the radioactive molecule guides the radiopharmaceutical to the tumor. “Radioactive” means that the molecule gives off a particle that can kill cancer cells. The risks of using radioactive drugs are small, and medical teams work to ensure the highest level of safety for everyone.
  • Information credited to Metastatic Trial Talk
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